26Jul 2019

Silvia Salvadori - “Ipsis verbis” Claim Language: Not Enough to Support a Sufficient Written Description Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories, Inc. is an interesting case, recently decided by the Federal Circuit. The claims at issue were directed to a pharmaceutical composition of a non-steroidal anti-inflammatory drug (NSAID) coated with a proton pump inhibitor (PPI). The aim of the invention was to provide a formulation of a NSAID which did not provoke bleeding in the stomach.

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09Jul 2019

Silvia Salvadori - USPTO: State of Patent Eligibility The Senate IP subcommittee recently held three public hearings on the state of patent eligibility. It clearly appeared that relatively recent U.S. Supreme Court decisions have left companies, universities, and investors confused and unable to understand what is patentable and what is not. The consequences are very important because currently, companies are reluctant to start investigating and investing time and money in areas that are not clearly identified as patent-eligible. Continue reading

20Jun 2019

Silvia Salvadori - Invention Patents Become Harder to Obtain. What Can Be Done?On May 22, 2019, the draft language of a bipartisan bill meant to amend  section 101 of 35 U.S.C. was released by Senators Tom Tillis and Chris Coons. The sponsors say the bill is needed because recent Supreme Court rulings have rendered more difficult to patent certain types of inventions (diagnostic methods, software, and business methods).

The consternation over the Court’s opinion rested not only on how limited the ability to protect critical innovations that drive the U.S. economy, but also how vague the Justices left the line between inventions that are eligible for patent and those that are not. The proposed modification includes changes in the language of the statute (35 U.S.C. § 101): Section 101: Continue reading

30Apr 2019

Silvia Salvadori - Provisional Patent Application Lessons: Adequate Specificity Provisional applications are generally used to provide a valid priority date for an invention claimed in a subsequent non-provisional application. However, even a well drafted provisional application may fail to describe the claimed invention with “adequate specificity.”

In a recent case, Purdue Pharma L.P. v. Iancu, the main claim was directed to a controlled release oral solid dosage form of oxycodone. The patent was challenged and found invalid as obvious. The plaintiff appealed. Continue reading

05Mar 2019

Silvia Salvadori - Patent Term Adjustment Deductions — Important Lessons

In the recent decision Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit held that the USPTO wrongly imposed a Patent Term Adjustment (PTA) to the applicant for an Information Disclosures Statement (IDS) filed after a Request for Continued Examination (RCE).

Patent Term Adjustment Statute

The PTA statute establishes that an award in patent term should correspond to a deduction (of patent term) for any delay caused by the applicant’s failure to engage in activities that aim to conclude prosecution of the application. Under PTA rules, the USPTO can charge the applicant with a delay when the applicant files an IDS after having filed an RCE, but before the next Office Action or Notice of Allowance.  Continue reading

08Feb 2019

Silvia Salvadori - USPTO Update: Revised Patent Subject Matter Eligibility Guidance On January 7, 2019 the United States Patent and Trademark Office (USPTO) issued a Revised Patent Subject Matter Eligibility Guidance in the Federal Register Notice. The Guidance revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under Step 2A of the USPTO’s Subject Matter Eligibility Guidance in two ways. Continue reading

10Jan 2019

Silvia Salvadori - USPTO Announces RPA Initiative for Continuing Applications  The United States Patent and Trademark Office (USPTO) is implementing the first phase of the Access to Relevant Prior Art Initiative (“RPA Initiative”) to import from the immediate parent application into the continuing application.

RPA Initiative Explained:

In a continuing application, the citations corresponding to the documents considered by the examiner will be printed on the face of the patent issuing from the continuing application without the applicant having to resubmit the information on an Information Disclosure Statement. Additionally, an applicant’s duty to disclose information in the continuing application will continue to be satisfied for information considered in the parent application — and will be satisfied for any additional information made of record by the USPTO  in the continuing application.

The USPTO plans to implement the RPA Initiative in phases, to consider and address public and examiners’ feedback at each phase and determine how to effectively expand the RPA Initiative in future phases. Continue reading

20Nov 2018

Silvia Salvadori - Roche Molecular Systems, Inc. v. CepheidIn a recent case, Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed that claims directed to a nucleotide primer and claims directed to a detection method are invalid under 35 USC § 101.

The patent covered primers and methods for a rapid detection of M. tuberculosis on the basis of the presence of nucleotides specific for M. tuberculosis (MTB). Continue reading

12Oct 2018

Silvia Salvadori - Patent Law: 4 Ways to Overcome Obviousness Rejections In a recent case, E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit outlined four (4) ways to overcome obviousness rejections based on routine optimization. The patent at issue covered methods for preparing a compound under reaction conditions already described in three prior art references.

The court made reference to the classic rationales to support an obviousness rejection. That is, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation,” and “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” Continue reading

10Sep 2018

Silvia Salvadori - Understanding the Difference Between Prior Art Publication and Prior UseIn a recent case, Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the validity of two patents listed in the Orange Book. This decision is significant because it illustrates the difference between prior art publication vs. prior use.

Below, some of the claim language is included, including two noteworthy claims under litigation — dependent Claim 2 and Claim 18:

Claim 1) A composition formulated for intramuscular injection in a form for single injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a mixture of castor oil and benzyl benzoate wherein the vehicle contains castor oil in a concentration of 40 to 42% vol. Continue reading